Kornimate/medical-research-clean huggingface dataset:
a comparison of the effectiveness of two types of memory training programs in people with a diagnosis of mental illness.

Conditions: Memory Impairment

Summary: this study will compare the effectiveness of a psychoeducational memory program versus a computerized memory program in individuals with mental illness. although improvements are expected with both form of interventions, we do not know which will provide maximal benefit in this population.

the aim of the current study is to compare two memory strategies, a top-down (i.e., educational and interventional)protocol vs. a bottom-up (computerized)protocol, in a population of individuals diagnosed with mental illness. performance on ecologically validated memory tasks will be measured before and after each intervention protocol. improvements are expected following each protocol. however, there is no evidence available to support added benefits from one protocol over another. as such, the current study will endeavour to contrast the two intervention types (top-down vs. bottom-up) to determine which, if any, provides maximal benefit.

Eligibility criteria:
inclusion criteria: * memory impairment equivalent to 1.5 std. dev. below average for age * speak and read english fluently exclusion criteria: * older than 65 years of age * significant visual impairment (e.g., cataracts, macular degeneration) * motor impairment (e.g., hemiplegia on dominant side) * diagnosis of dementia * alcohol and/or substance abuse (in past 3 months)

Keywords: memory intervention computerized psychoeducational mental illness
sublingual administration of ppi

Conditions: Gastric or Duodenal Ulcer

Summary: compare 24-hour intragastric ph and therapeutic effectiveness of proton pump inhibitor (ppi) among different administration methods: per oral (po), intravenous (iv), and sublingual (sl).

intragastric ph and therapeutic effectiveness of ppi was compared among patients given ppi with different administration methods. 24 hour intragastric ph catheter was inserted in stomach of patients with peptic ulcer an hour prior to ppi administration in order to observe the initial change in ph. three groups of patients were given ppi through per oral, intravenous, and sublingual administration methods. the hypothesis of this study is that sublingual administration will be faster than oral or iv administration in ppi dosing with respect to intragastric ph change and re-bleeding rate.

Eligibility criteria:
inclusion criteria: * patients with peptic ulcer disease * age: 20-75 years old * patients who submitted informed consent exclusion criteria: * peptic ulcer disease with spurting and oozing * shock, hypotension, pregnancy * gastrointestinal malignancy

Keywords: gastric ulcer duodenal ulcer re-bleeding rate intragastric ph proton pump inhibitor
des versus bioss lim - polbos ii study

Conditions: Coronary Artery Disease

Summary: coronary bifurcation lesions pose therapeutic problems during percutaneous coronary interventions (pci) and are associated with higher rates of periprocedural complications as well as higher rates of in-stent restenosis and stent thrombosis. provisional t-stenting (pts) is the best treatment strategy at the moment. however, the optimal approach to coronary bifurcations treatment is still a subject of debate, especially when the side branch is large, not easily accessible and narrowed by a long lesion. one of the proposed alternatives are dedicated bifurcation stents (dbs). however, there is large scarcity of randomized trials with dbs. polbos ii study is continuation of polbos i (polish bifurcation optimal stenting) study, in which paclitaxel-eluting stent bioss expert® (balton, poland) was assessed. now performance of sirolimus-eluting stent bioss lim® (balton, poland) is verified.

after signing the informed consent patients were randomly assigned to one of two treatment strategies: bioss lim® stent implantation or rdes implantation (envelope randomization, 1:1). if the patient was enrolled to rdes group there was a second randomization: with or without final kissing ballooning (fkb). clinical follow-up was performed with office visits or telephone contacts at 1 and 12 months after intervention. adverse events were monitored throughout the study period. follow-up coronary angiography was performed at 12 months unless clinically indicated earlier.

Eligibility criteria:
inclusion criteria: * stable coronary artery disease (cad) or non-st-segment elevation acute coronary syndrome (nste-acs) * age ≥ 18 years old, * de novo coronary bifurcation lesion (including unprotected lms), * mv diameter ≥ 2.5 mm and sb diameter ≥ 2.0 mm assessed by visual estimation. exclusion criteria: * st-elevation myocardial infarction (stemi), * bifurcations with medina type 0,0,1, * serum creatinine level ≥ 2.0 mg/dl, * inability to take dual antiplatelet therapy for 12 months, * left ejection fraction ≤ 30% * lack of an informed consent

Keywords: dedicated bifurcation stent sirolimus eluting stent
crossover bioequivalence study of irbesartan 300 mg tablets under fed conditions

Conditions: Hypertension

Summary: the objective of this study was to prove the bioequivalence of roxane laboratories' irbesartan 300 mg tablets under fed conditions.


Eligibility criteria:
inclusion criteria: 1. male and female subjects between the ages of 18 and 45 years (inclusive). 2. voluntary consent to participate in the study. 3. body mass index (bmi) between 18 and 30 (inclusive). 4. female subjects of childbearing potential - not surgically sterile or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception from screening through completion of the study: abstinence, hormonal (oral, implant, transdermal, or injection) for at least 3 months prior to the first dose of the study, barrier (condom with spermicide, diaphragm with spermicide), iud, or vasectomized partner (6 months minimum). 5. no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: 1. a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results. 2. a history of allergic or adverse responses to irbesartan, or any comparable or similar product. 3. subjects who (for whatever reason) have been on an abnormal diet or have had substantial changes in eating habits within 30 days prior to study initiation. 4. subjects must not have made a blood donation of one pint or more within 30 days prior to study initiation. 5. subjects must not have made a plasma donation within 14 days of study initiation. 6. participation in a clinical trial within 30 days prior to study initiation. 7. use of any over-the-counter (otc) medication, including vitamins, herbal products, and dietary supplements, within 7 days prior to or during the study. 8. use of any prescription medication within 7 days prior to or during the study, with the exception of hormonal contraceptives for women of childbearing potential, or hormone replacement therapy. 9. treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, phenytoin, rifampin, rifabutin, glucocorticoids, diltiazem, ketoconazole, maoi, antidepressants, neuroleptics, verapamil, quinidine, erythromycin, etc., within 30 days prior to or during the study. 10. smoking or use of tobacco products within 6 months prior to or during the study. 11. female subjects who are lactating. 12. positive serum pregnancy test for female subjects. 13. positive blood screen for hiv, hepatitis b or hepatitis c. 14. positive screen for alcohol or drugs of abuse, and history or presence of alcoholism or drug abuse within 6 months prior to the study start.
online brain training intervention for over 50s

Conditions: Dementia; Mild Cognitive Impairment

Summary: this study is an open trial investigating the long-term use of an online brain training programme for adults over 50. it will determine whether there is sustained benefit to cognition, and whether this group can be engaged in this form of intervention over a period of 12 months.

this study will evaluate an optimised brain training programme to determine whether it is engaging for older adults and whether it results in improvement or maintenance of cognition over a 12 month period. the brain training intervention the programme is an updated version of the original 'brain test britain' intervention, which was successfully evaluated in a large previous trial. it consists of a series of games or tests, completed on a computer. each test is designed to target the participants' reasoning and problem-solving ability, for example by asking them to balance weights on a see-saw or select the 'odd-one-out' from a series of shapes. as the participants progress over the course of the study they will receive increasingly more challenging versions of each test, depending on their performance. the intervention has been updated from the original to improve engagement through improved visuals, more intelligent difficulty setting and a more engaging delivery platform. the research delivery platform: protect a novel infrastructure resource has been developed at king's college london within the maudsley biomedical research unit for dementia (bru-d), which provides the opportunity to deliver the intervention to large numbers of older adults. the platform for research online to investigate cognition and genetics in ageing (protect) is an online research tool. protect is currently recruiting a cohort of over 10,000 adults over 50 who are cognitively healthy or have early cognitive impairment. participants provide demographic and lifestyle information and will complete a battery of validated cognitive assessments annually. the focus of all research conducted through protect is on the prevention of dementia and risk reduction. the optimised brain training intervention will be delivered through this platform. protect has ethical approval from the nhs research ethics service committee for london bridge (ref: 13/lo/1578). study design design: 12-month open online clinical trial participants: 5000 adults over 50 setting: intervention delivered at home, online through the protect website recruitment recruitment will be achieved through the protect site through a national advertisement strategy. this will be accomplished through partnerships with the media and third sector. all participants registered on protect will be invited to take part and provided with the information sheet. participants will consent through the secure online procedure on the protect site.

Eligibility criteria:
inclusion criteria: * over 50, * have access to a computer and the internet * registered as a participant on the protect website exclusion criteria: * established diagnosis of dementia

Keywords: healthy ageing
specialty medical homes to improve outcomes for patients with ibd and behavioral health conditions

Conditions: Inflammatory Bowel Disease; Behavioral Symptoms

Summary: a comparative effectiveness study using an individual-level randomized design along with a pragmatic, mixed-methods approach to compare two strategies (e.g. in-person supported care, technology-supported care) all of which include evidence-based components for delivering ibd and bh care. quantitative (e.g. self-report, electronic health record, process) and qualitative (e.g., interviews) data will be collected across multiple time points during the study period.

the investigators propose to conduct a comparative effectiveness research (cer) study of two evidence-based, patient-centered approaches implemented within an existing specialty medical home (smh) model: team, an in-person, multidisciplinary team-based approach delivered at point of care and tech, a technology-based (digital therapeutics, and telehealth) approach delivered at the patient's convenience with the guidance of health coaches. both are designed to support care for adult patients with complex, chronic health conditions and behavioral health (bh) disorders, and will be tested in three of the nation's largest and most established smhs for inflammatory bowel disease (ibd). ibd serves as an exemplary chronic disease model where untreated bh issues have been associated with poor medical outcomes.

Eligibility criteria:
inclusion criteria: * inflammatory bowel disease diagnosis of crohn's or ulcerative colitis. behavioral health symptoms mild to severe, defined as a score of \>= 6 on the personal health questionnaire 4 (phq4) exclusion criteria: * lack of smart phone, and/or are unable to speak, read or understand english at the minimum-required level.
icotinib as adjuvant therapy in treating non-small-cell lung cancer patients with positive egfr mutation

Conditions: Non-small-cell Lung Cancer

Summary: this study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. the primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib.

adjuvant therapy has been proved effective in treating stage ii-iiia non-small-cell lung cancer. however, few data on the treating time of adjuvant therapy is available. here we conduct a randomized, prospective study to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib in egfr-mutated non-small cell lung cancer patients.

Eligibility criteria:
inclusion criteria: * the patients signed the written informed consent * the patients present with operable stage ii-iiia non-small-cell lung cancers with 19 or 21 exon mutation * the patients have no history of anti-cancer therapies including chemotherapy, radiation therapy * the patients' eastern cooperative oncology group scores are ≤ 0-2 exclusion criteria: * patients with unresected tumor * wild egfr type * allergic to the study drug * patients have severe non-cancerous diseases * patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials
automated quantification of radiologic pulmonary alteration during acute respiratory failure

Conditions: SARS-CoV-2 Infection; Respiratory Failure With Hypoxia

Summary: automated quantification of the pulmonary volume impaired during acute respiratory failure could be helpful to assess patient severity during covid-19 infection or perioperative medicine, for example. this study aim at assessing the correlation between the amount of radiologic pulmonary alteration and the clinical severity in two clinical situation : 1. sars-cov-2 infections 2. postoperative hypoxemic acute respiratory failure


Eligibility criteria:
inclusion criteria: * patient with insurance covering * patient admitted to the participating hospitals for sars-cov-2 infection or postoperative acute hypoxemic respiratory failure between 01/01/2019 and 05/11/2020 exclusion criteria: - patient transferred to another hospital than the participating center during the 7 days following the ct scan
pilot study of cyclophosphamide in patients with life-threatening systemic lupus erythematosus or antiphospholipid antibody syndrome

Conditions: Systemic Lupus Erythematosus; Antiphospholipid Antibody Syndrome

Summary: objectives: i. determine the induction of durable remission in patients with life-threatening systemic lupus erythematosus or antiphospholipid antibody syndrome treated with cyclophosphamide. ii. determine the toxicity of this drug in these patients.

protocol outline: patients receive cyclophosphamide iv on days 1-4 and filgrastim (g-csf) beginning on day 10 and continuing until blood counts recover. patients are followed monthly for 6 months, and then every 3 months thereafter.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnosis of life-threatening systemic lupus erythematosus (sle); must show at least 4 american college of rheumatology criteria for sle; must have severe organ damage in 1 or more organs; must have 1 or more of the following indications of ongoing disease activity: disease activity score (sledai) at least 4, hospitalization for disease activity within 12 months, life-threatening disease not captured on sledai or diagnosis of antiphospholipid antibody syndrome by the hughes criteria; must show severity by ongoing symptoms or signs of hypercoagulability in spite of warfarin therapy --patient characteristics-- hepatic: bilirubin no greater than 2.0 mg/dl; transaminases no greater than 2.0 times normal renal: creatinine no greater than 3.0 mg/dl cardiovascular: ejection fraction at least 45% pulmonary: fvc, fev1, or dlco at least 50% predicted other: not preterminal or moribund; not pregnant or nursing; fertile patients must use effective contraception

Keywords: antiphospholipid antibody syndrome arthritis & connective tissue diseases immunologic disorders and infectious disorders rare disease systemic lupus erythematosus
a randomized, open-label, single dose, parallel study to evaluate the pharmacokinetics dose proportionality of gla5pr glars-nf1 tablet in healthy male volunteers

Conditions: Healthy

Summary: the purpose of this clinical trial is to compare the pharmacokinetic characteristics of gla5pr glars tablet 150mg and lyrica capsule 75mg. gla5pr glars tablet 150mg is a new formulation which is made by gl pharm tech. glars(geometrically long absorption regulated system) is new solution to sustained absorption by extending the absorption site. to overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. the investigators coined this "geometrically long absorption regulated system(glars)".

basically, this system is a triple-layered tablet, comprised of upper and lower layers that swell and draw a sufficient amount of water, plus a highly water - soluble middle layer that rapidly draw water into the tablet core simultaneously. the water drawn into the tablet (about 3 to 4 times the weight of the tablet itself) functions as an additional media which enables additional and later drug release out of the dosage form. this serves to overcome the shortage of surrounding media that has been reported to be one of the key reasons for mal-absorption of a drug in colon. as the middle layer induces a rapid water draw into the tablet core, the penetrated water also diffuses to the upper and lower layers, which makes the tablet to rapidly swell and controls drug release. at virtually the same time, the swollen upper and lower layers form to surround a lateral side of the middle layer, which can, in turn, further control drug release. this relatively rigid swollen matrix structure makes drug release not affected by surrounding mechanical flux, which can provide relatively consistent in vivo drug release irrespective of degree of gastrointestinal motility.

Eligibility criteria:
inclusion criteria: * 19\~45 years old, healthy adult male subject * 17.5\~30.5kg/m2(bmi) and ≥ 40kg(body weight) exclusion criteria: * sbp ≥ 140mmhg or dbp ≥ 90mmhg
reproducibility of magnetic resonance myocardial salvage index

Conditions: Myocardial Infarction

Summary: the myocardial salvage assessed by using multimodal cardiac magnetic resonance imaging is a rather new technique which can be used as a surrogate endpoint to reduce the sample size in studies comparing different reperfusion strategies in myocardial infarction. as reproducibility of myocardial salvage has not been evaluated appropriately, we aim to scan 20 patients on 2 subsequent days to evaluate reproducibility of myocardial salvage index.


Eligibility criteria:
inclusion criteria: * st-elevation myocardial infarction * primary percutaneous coronary intervention exclusion criteria: * contraindications for magnetic resonance imaging

Keywords: reproducibility contrast agent magnetic resonance imaging infarct size myocardial salvage index myocardial salvage assessment
international study of childhood obesity, lifestyle and the environment

Conditions: Childhood Obesity

Summary: the primary aim of the international study of childhood obesity, lifestyle and the environment (iscole) is to determine the relationship between lifestyle characteristics and obesity in a large multi-national study of 10 year-old children, and to investigate the influence of behavioral settings and physical, social and policy environments on the observed relationships within each country.

data will be collected in 12 countries (500 children per site) from five major regions of the world (eurasia \& africa, europe, latin america, north america, and the pacific). cross-sectional evaluations will be undertaken in each country. the physical characteristics of the children will be directly measured in order to classify their body weight and adiposity status, and physical activity and dietary patterns will be measured with the most objective techniques currently available. a concise set of environmental measures that are feasible, valid and meaningful across the international settings included in this research will also be employed. the results of this study will provide a robust examination of the correlates of obesity and weight gain in children, focusing on both sides of the energy balance equation. the results will also provide important new information that will inform the development of lifestyle interventions to address childhood obesity that can be culturally adapted for implementation around the world.

Eligibility criteria:
inclusion criteria: * students 10 years of age exclusion criteria: * has pacemaker or other internal medical devices

Keywords: international childhood obesity iscole pennington biomedical research center pbrc longitudinal multinational